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Last Updated: December 4, 2024

PREPOPIK Drug Patent Profile


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Which patents cover Prepopik, and when can generic versions of Prepopik launch?

Prepopik is a drug marketed by Ferring Pharms Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-two patent family members in twenty-five countries.

The generic ingredient in PREPOPIK is citric acid; magnesium oxide; sodium picosulfate. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the citric acid; magnesium oxide; sodium picosulfate profile page.

DrugPatentWatch® Generic Entry Outlook for Prepopik

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (citric acid; magnesium oxide; sodium picosulfate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for PREPOPIK
Drug Prices for PREPOPIK

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Drug Sales Revenue Trends for PREPOPIK

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Recent Clinical Trials for PREPOPIK

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The Cleveland ClinicPhase 4
Ferring PharmaceuticalsPhase 4
Ferring PharmaceuticalsPhase 3

See all PREPOPIK clinical trials

Paragraph IV (Patent) Challenges for PREPOPIK
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PREPOPIK Oral Solution citric acid; magnesium oxide; sodium picosulfate 10 mg, 3.5 g, and 12 g 202535 1 2014-05-21

US Patents and Regulatory Information for PREPOPIK

PREPOPIK is protected by two US patents.

Patents protecting PREPOPIK

Granular compositions of sodium picosulphate and potassium bicarbonate and uses thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Granular compositions of magnesium oxide and citric acid and uses thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ferring Pharms Inc PREPOPIK citric acid; magnesium oxide; sodium picosulfate FOR SOLUTION;ORAL 202535-001 Jul 16, 2012 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Ferring Pharms Inc PREPOPIK citric acid; magnesium oxide; sodium picosulfate FOR SOLUTION;ORAL 202535-001 Jul 16, 2012 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for PREPOPIK

When does loss-of-exclusivity occur for PREPOPIK?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 08309287
Patent: Process for the manufacure of a pharmaceutical product comprising citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate, pharmaceutical composition comprising granules obtained by such process and intermediate
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0818541
Patent: Processo para a produção de um produto farmacêutico
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 02152
Patent: PROCEDE DE FABRICATION D'UN PRODUIT PHARMACEUTIQUE (PROCESS FOR THE MANUFACTURE OF A PHARMACEUTICAL PRODUCT)
Estimated Expiration: ⤷  Sign Up

China

Patent: 1406457
Patent: Process for the manufacture of a pharmaceutical product
Estimated Expiration: ⤷  Sign Up

Patent: 1820859
Patent: Process for the manufacure of pharmaceutical product comprising citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate, pharmaceutical composition comprising granules obtained by such process and intermediate
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0180215
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 07526
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 07526
Patent: PROCÉDÉ DE FABRICATION D'UN PRODUIT PHARMACEUTIQUE CONTENANT DE L'ACIDE CITRIQUE, DE L'OXYDE DE MAGNÉSIUM, DU BICARBONATE DE POTASSIUM ET DU PICOSULFATE DE SODIUM, COMPOSITION PHARMACEUTIQUE CONTENANT DES GRANULES ET LEUR PRODUIT INTERMEDIAIRE (PROCESS FOR THE MANUFACURE OF A PHARMACEUTICAL PRODUCT COMPRISING CITRIC ACID, MAGNESIUM OXIDE, POTASSIUM BICARBONATE AND SODIUM PICOSULFATE, PHARMACEUTICAL COMPOSITION COMPRISING GRANULES OBTAINED BY SUCH PROCESS AND INTERMEDIATE PRODUCTS THEREOF)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 38174
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 4500
Patent: תהליך לייצור הרכב או הרכב רוקחי על ידי ריסוס ציפוי של שכבת נתרן פיקוסולפאט על גרעין של אשלגן ביקרבונאט (Process for the manufacture of a composition or pharmaceutical composition comprising spray coating a layer of sodium picosulphate on a core of potassium bicarbonate)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 54873
Estimated Expiration: ⤷  Sign Up

Patent: 11500549
Estimated Expiration: ⤷  Sign Up

Jordan

Patent: 06
Patent: عملية لتصنيع منتج صيدلاني يشتمل على حمض الستريك ،أكسيد ماغنسيوم، بيكربونات بوتاسيوم وبيكو كبريتات صوديوم، تركيبة صيدلانية تشتمل على حبيبات متحصل عليها بواسطة هذه العملية ومنتجات وسيطة منها (PROCESS FOR THE MANUFACURE OF A PHARMACEUTICAL PRODUCT COMPRISING CITRIC ACID, MAGNESIUM OXIDE, POTASSIUM BICARBONATE AND SODIUM PICOSULFATE, PHARMACEUTICAL COMPOSITION COMPRISING GRANULES OBTAINED BY SUCH PROCESS AND INTERMEDIATE PRODUCTS THEREOF)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 07526
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 10003588
Patent: PROCESO PARA LA MANUFACTURA DE UN PRODUCTO FARMACEUTICO. (PROCESS FOR THE MANUFACTURE OF A PHARMACEUTICAL PRODUCT.)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 3899
Patent: PROCESS FOR THE MANUFACURE OF A PHARMACEUTICAL PRODUCT COMPRISING CITRIC ACID, MAGNESIUM OXIDE, POTASSIUM BICARBONATE AND SODIUM PICOSULFATE, PHARMACEUTICAL COMPOSITION COMPRISING GRANULES OBTAINED BY SUCH PROCESS AND INTERMEDIATE
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 07526
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 07526
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 73332
Patent: СПОСОБ ИЗГОТОВЛЕНИЯ ФАРМАЦЕВТИЧЕСКОГО ПРОДУКТА, СОДЕРЖАЩЕГО ЛИМОННУЮ КИСЛОТУ, ОКСИД МАГНИЯ, БИКАРБОНАТ КАЛИЯ И ПИКОСУЛЬФАТ НАТРИЯ, ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ГРАНУЛЫ, ПОЛУЧЕННЫЕ ТАКИМ СПОСОБОМ, И ПРОМЕЖУТОЧНОЕ СОЕДИНЕНИЕ (METHOD OF MANUFACTURING PHARMACEUTICAL PRODUCT, CONTAINING CITRIC ACID, MAGNESIUM OXIDE, POTASSIUM BICARBONATE AND SODIUM PICOSULFATE, PHARMACEUTICAL COMPOSITIONS, CONTAINING THUS OBTAINED GRANULES AND INTERMEDIATE COMPOUND)
Estimated Expiration: ⤷  Sign Up

Patent: 10112483
Patent: СПОСОБ ИЗГОТОВЛЕНИЯ ФАРМАЦЕВТИЧЕСКОГО ПРОДУКТА, СОДЕРЖАЩЕГО ЛИМОННУЮ КИСЛОТУ, ОКСИД МАГНИЯ, БИКАРБОНАТ КАЛИЯ И ПИКОСУЛЬФАТ НАТРИЯ, ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ГРАНУЛЫ, ПОЛУЧЕННЫЕ ТАКИМ СПОСОБОМ, И ПРОМЕЖУТОЧНОЕ СОЕДИНЕНИЕ
Estimated Expiration: ⤷  Sign Up

Saudi Arabia

Patent: 290670
Patent: عملية تصنيع خاصة بمنتج صيدلاني من بيكوكبريتات الصوديوم (Manufacturing Process for a Pharmaceutical Sodium Picosulphate Product)
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 07526
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1002131
Patent: PROCESS FOR THE MANUFACTURE OF A PHARMACEUTICAL PRODUCT COMPRISING CITRIC ACID,MAGNESIUM OXIDE,POTASSIUM BICARBONATE AND SODIUM PICOSULFATE,PHARMACEUTICAL COMPOSITION COMPRISING GRANULES OBTAINED BY SUCH PROCESS AND INTERMEDIATE
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1330096
Estimated Expiration: ⤷  Sign Up

Patent: 1381263
Estimated Expiration: ⤷  Sign Up

Patent: 100072020
Patent: PROCESS FOR THE MANUFACTURE OF A PHARMACEUTICAL PRODUCT COMPRISING CITRIC ACID, MAGNESIUM OXIDE, POTASSIUM BICARBONATE AND SODIUM PICOSULFATE, PHARMACEUTICAL COMPOSITION COMPRISING GRANULES OBTAINED BY SUCH PROCESS AND INTERMEDIATE
Estimated Expiration: ⤷  Sign Up

Patent: 130105757
Patent: PROCESS FOR THE MANUFACTURE OF A PHARMACEUTICAL PRODUCT COMPRISING CITRIC ACID, MAGNESIUM OXIDE, POTASSIUM BICARBONATE AND SODIUM PICOSULFATE, PHARMACEUTICAL COMPOSITION COMPRISING GRANULES OBTAINED BY SUCH PROCESS AND INTERMEDIATE
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 59716
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 18352
Estimated Expiration: ⤷  Sign Up

Patent: 0924759
Patent: Process for the manufacture of a pharmaceutical product
Estimated Expiration: ⤷  Sign Up

United Kingdom

Patent: 05953
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PREPOPIK around the world.

Country Patent Number Title Estimated Expiration
Taiwan I418352 ⤷  Sign Up
Denmark 2207526 ⤷  Sign Up
South Korea 20100072020 PROCESS FOR THE MANUFACTURE OF A PHARMACEUTICAL PRODUCT COMPRISING CITRIC ACID, MAGNESIUM OXIDE, POTASSIUM BICARBONATE AND SODIUM PICOSULFATE, PHARMACEUTICAL COMPOSITION COMPRISING GRANULES OBTAINED BY SUCH PROCESS AND INTERMEDIATE ⤷  Sign Up
European Patent Office 2207526 PROCÉDÉ DE FABRICATION D'UN PRODUIT PHARMACEUTIQUE CONTENANT DE L'ACIDE CITRIQUE, DE L'OXYDE DE MAGNÉSIUM, DU BICARBONATE DE POTASSIUM ET DU PICOSULFATE DE SODIUM, COMPOSITION PHARMACEUTIQUE CONTENANT DES GRANULES ET LEUR PRODUIT INTERMEDIAIRE (PROCESS FOR THE MANUFACURE OF A PHARMACEUTICAL PRODUCT COMPRISING CITRIC ACID, MAGNESIUM OXIDE, POTASSIUM BICARBONATE AND SODIUM PICOSULFATE, PHARMACEUTICAL COMPOSITION COMPRISING GRANULES OBTAINED BY SUCH PROCESS AND INTERMEDIATE PRODUCTS THEREOF) ⤷  Sign Up
Saudi Arabia 08290670 عملية تصنيع خاصة بمنتج صيدلاني من بيكوكبريتات الصوديوم (Manufacturing Process for a Pharmaceutical Sodium Picosulphate Product) ⤷  Sign Up
Portugal 2207526 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.